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NDC 42358-0295-01 Nulibry 9.5 mg/1 Details
Nulibry 9.5 mg/1
Nulibry is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sentynl Therapeutics, Inc.. The primary component is FOSDENOPTERIN HYDROBROMIDE.
Product Information
| NDC | 42358-0295 |
|---|---|
| Product ID | 42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4 |
| Associated GPIs | |
| GCN Sequence Number | 081982 |
| GCN Sequence Number Description | fosdenopterin hydrobromide VIAL 9.5 MG INTRAVEN |
| HIC3 | Z10 |
| HIC3 Description | METABOLIC DISEASE ENZYME REPLACEMENT, MOCD |
| GCN | 49269 |
| HICL Sequence Number | 047158 |
| HICL Sequence Number Description | FOSDENOPTERIN HYDROBROMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Nulibry |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fosdenopterin hydrobromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 9.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | FOSDENOPTERIN HYDROBROMIDE |
| Labeler Name | Sentynl Therapeutics, Inc. |
| Pharmaceutical Class | Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214018 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42358-0295-01 (42358029501)
| NDC Package Code | 42358-295-01 |
|---|---|
| Billing NDC | 42358029501 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |